CANSLEEP-MS
Study Overview:
The majority of people with MS experience problems with sleep, pain, or both. Sleep problems affect more than half of people with MS. Sleep problems also have the potential to worsen chronic pain, which affects about half of people with MS. We hope to learn more about the pain-sleep connection.
What do I have to do?
If you participate in this study, you will start off with a 2-3 hour in-person visit, your first overnight sleep study, and your first 14-day “home monitoring” session with the PRO-Diary watch. We will ask you to provide about three teaspoons of blood at your initial visit and at the mid-treatment and final treatment timepoints.
After the 14-day home monitoring (PRO-Diary watch), you will be assigned 1 of 4 treatments as detailed below. Randomization and treatment delivery may be in person, or done virtually (without an in-person visit). If done virtually, study drug may be shipped directly to your home.
1) Prescription CBD (in the form of liquid Epidiolex) + a placebo (inactive) version of THC capsule,
2) Prescription THC (in the form of dronabinol capsule) + a placebo (inactive) version of CBD liquid,
3) A combination of both prescription CBD and THC (in the form of liquid Epidiolex and dronabinol capsule),
4) Placebo (inactive) versions of both CBD and THC (capsule + liquid with no active drug in either product).
Complete two online surveys at about 6 and 12 weeks after you begin treatment.
Begin a second 14-day session of “home monitoring” 10 week after treatment starts.
Complete a second overnight sleep study just before the end of your 12 weeks of treatment.
You will also complete several scheduled follow-up phone calls with the study team (lasting about 15 minutes each).
These activities will occur over a duration of about 14 weeks (with treatment lasting 12 weeks). Additional unscheduled in-person or phone assessments may occur. We will also do a final follow-up call about 30 days after your treatment ends.
Participants will receive up to $400 for full study completion.
Who is eligible?
– Must be between 18 and 65 years old.
– Must have MS.
– Must have chronic pain.
Contact:
CANSLEEP-MS Study Staff: David Johnson or Shay Robison
Phone: (734) 936-2844
Email: cansleep-ms@med.umich.edu
Study ID: HUM00190734 IRB: IRBMED Date Approved: 11/3/2020
CogDetect-MS
Study Overview:
Cognitive dysfunction is common in many different clinical conditions, including multiple Multiple Sclerosis (MS). Little is known about the impact of cognitive dysfunction where it matters most – in the everyday lives of people with these conditions. This study is designed to examine the cognitive function in real-world settings in people with MS. We expect the knowledge gained in this study will lead us to new insights about how to measure cognitive functioning in daily life and better ways to improve overall health-related quality of life of people with MS.
What do I have to do?
– Participants in this study will complete 3 in-person study visits and 3 “home-monitoring periods” over the course of 2 years. Each in-person study visit is followed by a 14-day home-monitoring period.
– During the home-monitoring period, participants will wear an activity monitor on their wrist and use a study-provided smartphone to complete brief surveys and thinking tests 4 times per day.
– At the end of the home-monitoring period, participants will mail the devices back using pre-paid study-provided shipping boxes.
Participants will receive up to $600 for full study completion.
Who is eligible?
– Must be at least 18 years old.
– Must have MS.
– Must ambulate independently at least 50% of the time.
Contact:
CogDetect-MS Study Staff: Keara Ginell
Phone: (734) 936-2844
Email: cogdetect-ms@med.umich.edu
Study ID: HUM00199732 IRB: IRBMED Date Approved: 04/26/2022
